儿科孟鲁司特钠超说明书用药调查研究

Investigation and study on off-label drug use of montelukast sodium in pediatrics

目的了解孟鲁司特钠在儿科超说明书用药现状,为孟鲁司特钠作超说明书用药备案提供依据,促进孟鲁司特钠合理使用。方法调查门诊医院管理信息系统(Hospital information system,HIS),统计儿科孟鲁司特钠超说明书用药情况,对比孟鲁司特钠的说明书,评估超说明书用药的程度。结果孟鲁司特在儿科超说明书用药发生率为94.04%,主要表现为超适应证用药和超适用人群用药。其中,主要用于2岁以下儿童超适用人群用药占29.39%,1岁以下为10.36%。超适应证用药占93.52%,主要用于处方诊断为支气管炎、肺炎和咳嗽。结论孟鲁司特钠在儿科患者中超说明书用药现象较普遍,需要加强监控和管理,促进孟鲁司特钠超说明书用药备案。

Objective To investigate the status of off-label drug use of montelukast sodium in pediatrics,and to provide evidence for the record of off-label drug use of montelukast sodium,so as to promote the rational use of montelukast sodium.Methods The outpatient clinic hospital information system(HIS)was investigated,and the off-label use of montelukast sodium was statistically analyzed.The level of off-label use of montelukast sodium was evaluated by comparing the instruction of montelukast sodium.Results The incidence of montelukast sodium off-label drug use in pediatrics was 94.04%,mainly for over-indication drug use and for the super-applicable population.Among them,29.39%were mainly used for children under 2 years old,and 10.36%were for children under 1 year old.Over-indication drug use accounted for 93.52%,mainly for prescription diagnoses of bronchitis,pneumonia and cough.Conclusion The phenomenon of off-label drug use of montelukast sodium is common in pediatric patients,and it is necessary to strengthen the monitoring and management to promote the record of off-label drug use of montelukast sodium.